Generic Name: Programmer For Embedded Active Devices — Trade Name: Latitude Programming System 3300

Recalling firm: Name of Manufacturer and Distributor: Boston Scientific Japan K.K. — Address of Manufacturer and Distributor: Nakano Central Park South, 4-10-2 Nakano, Nakano-ku, Tokyo — Type of License: Class I...
Product: Lot: ラティチュードプログラミングシステム 3300 (モデル3300）出荷時期：2020年7月〜2025年11月数量：2,115台シリアル： 2201 3177 4374 5358 5701 5724 6909 7725 8029 8918 10273 13055 13121 13123 13124 13125 13126 13129 13130 13131 13133 13134 13135 13136 13137 13138 13139 13142 13143 13144 13145 13146 13147 13148 13149 13150 13151 13152 13153 13154 13155 13156 13157 13158 13159 13160 13161 13162 13163 13165 13166 13167 13168 13169 13170 13171 13172 13173 13174 13175 13176 13177 13178 13179 13180 13181 13182 13183 13184 13185 13186 13187 13188 13189 13190 13191 13192 13193 13194 13195 13196 13197 13198 13199 13200 13201 13202 13203...
Reason: For the implantable cardiac pacemakers Accolade (Approval No.: 22800BZX00168000) and Accolade MRI (Approval No.: 22700BZX00334000), as well as the implantable biventricular pacing pulse generator without defibrillation capability, Valitude (Approval No.: 22800BZX00187000) may transition to safety mode due to increased power consumption resulting from communication with the programmer, caused by a rise in internal battery resistance (hereinafter referred to as “this issue”). Consequently, in December 2024, in March and August 2025, we provided information regarding the aforementioned...
Classification: Class II
Category: medical device recall
Country: Japan
Agency: PMDA-DEVICE
Status: Ongoing

Recall details on Nibble Recalls: https://trynibble.app/recalls/0d97ce41-d4a8-48e3-96d2-73e508b60ca3